Recall: D-0112-2018

Class II - Potentially Harmful

Class IIClassification

2017-12-15Initiated

TerminatedStatus

B. Braun Medical IncFirm

Product

0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10

Reason

Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap

Distribution

Product was distributed nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.